SOLITAIRE FR4
Report
- Report Number
- 2029214-2020-01148
- Event Type
- Malfunction
- Date Received
- November 19, 2020
- Date of Event
- November 15, 2020
- Report Date
- January 20, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- NRY
- UDI-DI
- 00847536034730
- PMA / PMN Number
- K181060
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
H3: ANALYSIS OF THE SOLITAIRE X REVASCULARIZATION DEVICE (MODEL: SFR4-6-40-10, LOT: B042974), TREVO PRO 18 MICRO CATHETER AND TWO SOFIA CATHETERS FOUND NO DAMAGES OR IRREGULARITIES WITH THE TREVO PRO 18 MICRO CATHETER HUB. DRIED SALINE WAS FOUND WITHIN THE HUB. THE SOLITAIRE X PUSHER WAS FOUND EXTENDING OUT OF THE HUB ~41.1 CM. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE TREVO PRO 18 MICRO CATHETER BODY. THE TREVO PRO 18 MICRO CATHETER TIP AND MARKER BAND WAS FOUND CRUSHED. THE DISTAL SOLITAIRE STENT AND TREVO MICRO CATHETER WAS FOUND WITHIN A ROTATING HEMOSTATIC VALVE (RHV). THE DEVICES WERE REMOVED FROM THE RHV WITH LIGHT RESISTANCE ENCOUNTERED. THE TREVO PRO 18 MICRO CATHETER WAS FLUSHED, AND WATER EXITED OUT THE DISTAL END SLOWLY. THE SOLITAIRE X WAS THEN RETRACTED OUT OF THE TREVO PRO 18 WITH LIGHT RESISTANCE ENCOUNTERED AT THE DISTAL END. THE FINGER MARKERS WERE EXAMINED WITH NO DAMAGES FOUND. THE WORKING LENGTH STENT WAS FOUND ENTANGLED WITH A WIRE AND DRIED BLOOD. NO BENDS OR KINKS WERE FOUND WITH THE PUSHWIRE OR MARKER COIL. VISUAL INSPECTION SHOWED NO IRREGULARITIES OUTSIDE OF THE ATTACHMENT ZONE. THE STENT NON-WORKING (TEAR DROP) LENGTH STRUTS WERE IN GOOD CONDITION. THE INNER DIAMETER OF THE TREVO PRO 18 MICRO CATHETER WAS MEASURED TO BE 0.0215¿ AT THE PROXIMAL END. THE DISTAL INNER DIAMETER COULD NOT BE ACCURATELY MEASURED DUE TO THE CRUSHED TIP. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE FIRST SOFIA CATHETER HUB, BODY, DISTAL TIP AND MARKER BAND. UNDER MICROSCOPE VISUAL INSPECTION. THE INNER LINER WIRE WAS FOUND DAMAGED AND BROKEN BETWEEN ~8.6 CM AND ~16.1 CM FROM THE DISTAL END. THE BROKEN INNER WIRE WAS RETURNED SEPARATELY AND ENTANGLED ON THE SOLITAIRE X STENT. THE INNER DIAMETER OF THE SOFIA CATHETER WAS MEASURED TO BE 0.054¿ AT BOTH THE PROXIMAL AND DISTAL END. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE SECOND SOFIA CATHETER HUB OR CATHETER BODY. THE DISTAL TIP AND MARKER BAND WERE FOUND CRUSHED. THE INNER DIAMETER OF THE SOFIA CATHETER WAS MEASURED TO BE 0.054¿ AT THE PROXIMAL HUB. THE DISTAL TIP INNER DIAMETER COULD NOT BE MEASURED DUE TO THE DAMAGE. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿RESISTANCE DURING DELIV/RETRIEVAL¿ WAS CONFIRMED. IT IS LIKELY THE DAMAGES FOUND WITH THE RETURNED TREVO PRO-18 AND SOFIA CATHETERS CONTRIBUTED TO THE EVENT AS RESISTANCE WAS ENCOUNTERED AT THE DISTAL END OF THE CATHETER. POSSIBLE CAUSES FOR CATHETER DAMAGE ARE PATIENT VESSEL TORTUOSITY, CATHETER ENTRAPMENT, USER ADVANCES/RETRIEVES DEVICE AGAINST RESISTANCE, CATHETER ENTRAPMENT OR STENT REMOVED AGGRESSIVELY. THE CUSTOMER REPORT OF PUSHWIRE UNRAVELING WAS NOT CONFIRMED. THE WIRE FOUND ENTANGLING ON THE SOLITAIRE STENT IS LIKELY TO BE THE DAMAGED/BROKEN INNER WIRE OF ONE OF THE RETURNED SOFIA CATHETERS. THE CAUSE OF THE CATHETER DAMAGE COULD NOT BE DETERMINED. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C070601. CONCLUSION CODE UPDATED TO D15. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
NO ADDITIONAL INFORMATION RECEIVED.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S OCCLUSION WAS LOCATED IN THE MCA. IT WAS NOTED THAT THE UNRAVELLING MAY HAVE BEEN THE INNER THREADING OF THE INTERMEDIATE CATHETER, AND THAT THE DEVICES HAVE BEEN RETURNED TO CONFIRM. THE CLOT CHARACTERISTICS WERE "USUAL," THERE WAS NO VESSEL STENOSIS TO THE PROXIMAL THROMBUS SITE. THE PATIENT'S BASELINE NIHSS AND TICI WERE 0. THE FIRST PASS OF THE DEVICE SUCCESSFULLY REACHED THE THROMBUS, THERE WAS NO ISSUE DURING NAVIGATION OF THE MICROCATHETER, AND NO FRICTION DURING DELIVERY. THE SOLITAIRE WASNOT TORQUED OR REPOSITIONED DURING DELIVERY OR RETRIEVAL. POST PROCEDURE TICI WAS 3.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE X THAT HAD RESISTANCE DURING RETRIEVAL AND HAD DAMAGE TO THE PUSHWIRE. IT WAS REPORTED THAT THE NON-MEDTRONIC DISTAL ACCESS CATHETER WAS PLACED IN THE CAROTID TERMINUS. A NON-MEDTRONIC MICROCATHETER CROSSED THE OCCLUSION AND THE SOLITAIRE X WAS DEPLOYED. DURING RETRIEVAL, A SIGNIFICANT AMOUNT OF DRAG WAS FELT. UPON REMOVAL IT WAS NOTED THE PUSHWIRE WAS UNRAVELING THOUGHT HE DEVICE WAS ALREADY WITHIN THE CATHETER. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: SOFIA CATHETER, TREVO18 MICROCATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1334601 | SOLITAIRE FR4 | CATHETER, THROMBUS RETRIEVER | NRY | MICRO THERAPEUTICS, INC. DBA EV3 | SFR4-6-40-10 | B042974 | 00847536034730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |